RAPID framework for improved access to precision oncology for lethal disease: Results from a modified multi-round

Kristin Bright1,2, Anneliese Mills3, John-Peter Bradford4

  • 1Department of Anthropology, Middlebury College, Middlebury, VT, United States.

Abstract

Insights

Improving access to advanced cancer therapies requires addressing research costs, regulatory hurdles, and inequalities. Experts recommend an equity-centered model and government-industry collaboration for faster, fairer patient access to novel treatments.

Area of Science:

  • Oncology
  • Clinical Trials
  • Health Policy

Background:

  • Predictive oncology, germline technologies, and adaptive seamless trials offer promising advances for lethal cancers.
  • Access to these breakthrough therapies is significantly limited by high research costs, regulatory barriers, and systemic inequalities, exacerbated by the COVID-19 pandemic.

Purpose of the Study:

  • To develop a comprehensive strategy for rapid and equitable patient access to novel cancer therapies.
  • To identify and address systemic barriers hindering access to cutting-edge cancer treatments and clinical trials.

Main Methods:

  • A modified multi-round Delphi study involving 70 experts across oncology, clinical trials, regulatory affairs, patient advocacy, ethics, drug development, and health policy in Canada, Europe, and the US.
  • Semi-structured ethnographic interviews (n=33) were conducted to identify key issues and potential solutions.
  • Survey data (n=47) and interview findings were co-analyzed, followed by an in-person roundtable (26 participants) to draft system-change recommendations.

Main Results:

  • Experts highlighted significant patient access burdens related to time, cost, and transportation for trial eligibility and participation.
  • Only 12% of respondents expressed satisfaction with current research systems.
  • Top concerns identified were "patient access to trials" and "delays in study approval."

Conclusions:

  • An equity-centered precision oncology communication model is essential for improving access to adaptive seamless trials and reforming eligibility criteria.
  • Involving international advocacy groups is crucial for building patient trust and ensuring representation throughout research and therapy approval processes.
  • Governments, researchers, and payors must collaborate in an ecosystem approach to facilitate faster, equitable access to life-saving cancer therapeutics, considering individual patient circumstances.